Download London Cancer Anal Cancer Radiotherapy ERG Clinical Protocol

London Cancer
Guidelines for referral,
investigation and management
of Anal Carcinoma
May 2014
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Contents
1.0
TNM Classification ........................................................................................................... 3
PRIMARY TUMOUR ................................................................................................................................3
REGIONAL LYMPH NODES........................................................................................................................3
2.0
Pre-treatment assessment............................................................................................... 3
3.0
Radiotherapy Planning .................................................................................................... 4
3.1 PATIENT POSITIONING AND IMAGE ACQUISITION ...............................................................................4
3.2 CONVENTIONAL PLANNING VOLUMES ..............................................................................................4
3.3 IMRT PLANNING VOLUMES ...........................................................................................................5
GROSS CTV..........................................................................................................................................5
MESORECTAL CTV.................................................................................................................................5
PELVIC VESSELS .....................................................................................................................................5
NODAL CTV .........................................................................................................................................5
PRESACRAL CTV....................................................................................................................................5
CTV1..................................................................................................................................................5
PTV1..................................................................................................................................................5
PTV2..................................................................................................................................................5
RADIOTHERAPY TREATMENT ....................................................................................................................5
4.0 Policy and Radiation Prescription...................................................................................... 6
4.1
4.3
CURATIVE TREATMENT ....................................................................................................................... 6
PALLIATIVE TREATMENT FOR SYMPTOMATIC CONTROL (IF WIDESPREAD METASTATIC DISEASE).... 7
5.0
CRITICAL ORGANS AND TOLERANCE DOSES...................................................................... 7
6.0
Clinical Assessment during Radiotherapy ......................................................................... 8
7.0
Toxicity............................................................................................................................ 8
8.0
Gaps in Radiotherapy Treatment ..................................................................................... 8
9.0
Follow-up ....................................................................................................................... 8
10.0
Side Effects of Radiotherapy Treatment ......................................................................... 9
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1.0 TNM Classification
Primary Tumour
TX
T0
Tis
T1
T2
T3
T4
Primary tumour cannot be assessed
No evidence of primary tumour
Carcinoma in situ
Tumour 2 cm or less in greatest dimension
Tumour more than 2 cm but not more than 5 cm in greatest dimension
Tumour more than 5 cm in greatest dimension
Tumour any size directly invades other organs e.g. vagina, urethra, bladder (involvement of
the rectal wall, perirectal skin, subcutaneous tissue or sphincter muscle(s) alone is not
classified as T4)
Regional Lymph Nodes
NX
N0
N1
N2
N3
Regional lymph nodes cannot be assessed
No regional lymph node metastasis
Metastasis in perirectal lymph node(s)
Metastasis in unilateral internal iliac and/or unilateral inguinal lymph nodes(s)
Metastasis in perirectal and inguinal lymph nodes and/or bilateral internal iliac and/or
inguinal lymph nodes
2.0 Pre-treatment assessment
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History and examination.
Proctoscopy, EUA and biopsy. Histopathology results should be available.
Staging CT chest, abdomen and pelvis. PET-CT may be performed
MRI pelvis
Ultrasound guided biopsy of suspicious or enlarged inguinal nodes
Blood tests - FBC, U+E, LFTs.
Any other investigations considered necessary – this may include HIV testing
All patients should be discussed at the Anal Cancer MDT Meeting and the management strategy
agreed.
Patients should be given information sheets at their clinic attendance and afforded the
opportunity to discuss the treatment options in full.
Patients may require additional support and should be referred to other healthcare
professionals as appropriate e.g. to dietician, counsellor or stoma nurse.
Infertility and potential fertility preservation strategies should be discussed with all male
patients and with all female patients of child-bearing age. Effective contraception should also
be discussed with all patients due to have pelvic radiotherapy.
Informed consent is required for all patients
The Radiotherapy Management Plan should be devised as per the local guidelines
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3.0 Radiotherapy Planning
3.1
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Patient Positioning and Image Acquisition
Patients with anal margin tumours may be scanned and treated prone with the use of a “bellyboard” to enable accurate positioning of bolus. In all other patients, and those with margin
tumours but where patient mobility or body habitus precludes prone treatment, the patient
may be scanned and treated supine.
In patients with anal margin tumours or extension of tumour onto the perianal, perineal or
gluteal skin, bolus should be applied by the treating clinician at planning to ensure adequate
dose to this area.
If possible, an anal marker should be placed at scanning to define the clinical position of the anal
margin. In patients who are to be treated supine, this should be taped to the approximate
position for scanning.
Bowel preparation is not usually possible for anal cancer patients. Bladder preparation should
be followed such that the bladder is comfortably full for planning and treatment.
Intravenous contrast is required for all patients receiving radical treatment.
Patients will be scanned from 2cm superior to the top of L5 to 7cm below the anal marker with
3mm slices.
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Patients may be treated in a 2-phase technique (in line with the ACT II trial protocol) but it
anticipated that most will be treated with an IMRT solution with an integrated phase II.
3.2
Conventional Planning Volumes
GTV
 Visible tumour as seen on CT and PET-CT, taking into account the data from clinical examination
and MRI.
 Positive nodes on PET or biopsy should be defined as separate nodal GTVs.
PTV
 Phase I: Includes GTV and all areas at risk of microscopic disease (inguinofemoral nodes and
pelvic nodes). Always allow a minimum 3cm margin around any GTV in all directions. Field
borders should be defined on the posterior beam, using the same isocentre as the phase II
volume will have.
 Field Borders:
o Superior border: the more superior of (i) 2cm above the inferior aspect of the SacroIliac Joints or (ii) 3cm above superior limit of macroscopic disease including involved
lymph nodes 2 cm above inferior aspect of SI joints
o Lateral borders: approximately mid-point of femoral neck (to cover inguinal nodal
area)
o Inferior border: 3cm below anal verge or 3cm below inferior extent of tumor for anal
margin tumors. Be mindful that the inferior border of the phase 2 will be more than
3cm below the GTV and the phase I inferior border should match or exceed this.
 Phase II: PTV = GTV(s) + 3 cm
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3.3
IMRT planning volumes
GTV
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Visible tumour as seen on CT and PET-CT, taking into account the data from clinical examination
and MRI.
Positive nodes on PET or biopsy should be defined as separate nodal GTVs.
Gross CTV
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GTV (anal primary and involved nodes) + 2cm, trimmed to barriers of spread
Mesorectal CTV
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The entire mesorectum from the peritoneal reflection cranially to at least 3cm below the GTV
caudally. The cranial extent of this CTV may be amended in low, early, node-negative disease.
Pelvic Vessels
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Delineate the external and internal iliac vessels bilaterally from the bifurcation of the common
iliac vessels to the proximal femoral artery
Nodal CTV
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Pelvic Vessels + 0.7cm, trimmed to patterns of spread and amended to include any obvious
nodal regions (paying particular attention to the inguinal regions)
In node positive patients, the Nodal CTV should match the nodal portions of the Gross CTV.
Presacral CTV
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The pre-sacral nodal territory up to the L5/S1 interspace for patients with T3/4 disease or any
involved mesorectal lymph nodes
The nodal territory can be abbreviated to 2cm above the inferior aspect of the sacro-iliac joints
in patients with T1/2 tumours with no mesorectal lymph node involvement.
CTV1
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Merges Gross CTV, Mesorectal CTV, Nodal CTV and Pre-sacral CTV into one structure. This
should be checked again for coverage of patterns of spread and trimmed from barriers to
spread.
PTV1
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CTV1 + 0.5cm posteriorly and laterally and 1.0cm in all other directions.
PTV2
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Gross CTV + 0.5cm posteriorly and laterally and 1.0cm in all other directions.
It must be ensured that the PTV1 and 2 inferior and lateral extents are compared and it is
ensured that the PTV2 volume matches or is within the PTV1 volume.
Radiotherapy Treatment
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The clinician must approve, sign and date treatment images, plan and associated
documentation.
Patients should routinely receive oral ciprofloxacin 250mg b.d. prophylaxis commencing on
fraction 6 of radiotherapy.
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4.0 Policy and Radiation Prescription
4.1
CURATIVE TREATMENT
Conventional 2-phase technique
PHASE 1
30.6 Gy in 17 # over 3 weeks and 2 days
PHASE 2
19.8 Gy in 11# over 2 weeks and 1 day
For bulky tumours, consider dose escalation to 23.6Gy in 13# over 2 weeks and 3 days
TOTAL DOSE
50.4 Gy in 28# over 5 weeks and 3 days
Consider 54 Gy in 30# for bulky tumours
IMRT
These doses are the equivalent of a radical treatment dose of 54.6Gy in 1.8Gy fractions for a/b of
2Gy; and 35GY in 1.8Gy fractions. They therefore represent a slight dose increase in the radical dose
from ACT2 style dosing and a correction for overall treatment time for the elective volume.
PTV1 = PTV53.2
53.2Gy in 28 daily fractions over 5 weeks and 3 days (1.9Gy/fration)
Dose should be prescribed to the mean dose of PTV 53.2
PTV2 – PTV39.2
39.2Gy in 28 daily fractions over 5 weeks and 3 days (1.4Gy per fraction)
90% of the dose to the 39.2 dose level = 37.24Gy which equates to the 70% isodose with reference
to 53.2Gy
4.2
CHEMOTHERAPY
All patients receiving concurrent chemotherapy should have a peripherally inserted central catheter
(PICC line).
Radiotherapy to start no sooner than 2 hours after start of 5FU infusion
 For patients < 70 years old and no other significant co-morbidities:
o Mitomycin C 12 mg/m2 iv bolus (max 20mg) on day 1
o 5-Fluorouracil 1000 mg/m2 continuous infusion days 1-4 and days 29-32.
o In selected patients where platinum therapy may be beneficial, Cisplatin 60mg/m2 may
be substituted for the mitomycin and delivered in weeks 1 and 5.
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For patients >70 years or those with significant co-morbidities:
o Mitomycin C 10 mg iv bolus on day 1
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o 5-Fluorouracil 750 mg/m2 continuous infusion days 1-4 and days 29-32
Consider reducing 5FU dose if diarrhoea is severe at Week 5.
4.3 PALLIATIVE TREATMENT FOR SYMPTOMATIC CONTROL (IF WIDESPREAD METASTATIC
DISEASE)
 30Gy in 10# over 2 weeks +/- chemotherapy (Mitomycin C/5FU)
Or
 20Gy in 5# over 1 week
Or
 8Gy in 1# single fraction
5.0
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CRITICAL ORGANS AND TOLERANCE DOSES
Normal tissues outlined include bladder, femoral heads, pelvic bones, genitalia and small
bowel.
Bladder should be outlined from base to dome, excluding the CTV.
Any small bowel within 2cm of PTV should be outlined separately.
Genitalia should be delineated throughout the volume for both males and females.
Bladder
V30
V40
V50
80%
40%
0%
Small Bowel
V30
V40
V50
40%
30%
0%
Genitalia
V30
V40
V48
45%
10%
0%
Pelvic Bones
V15
V20
V50
45%
30%
0%
Femoral Heads
V45
V55
5%
0%
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6.0 Clinical Assessment during Radiotherapy
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Set up on machine to be seen if requested by clinician. On treatment imaging, including daily
kilovoltage imaging should follow standard departmental protocols. Cone-Beam CT may be used
fractions 1-3 and then weekly to assess soft tissue reproducibility not evident on kilovoltage
imaging.
Weekly review at on-treatment clinic to inspect perineum and natal cleft.
7.0 Toxicity
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Skin reaction
- For dry desquamation severe erythema apply aqueous cream
- For moist desquamation, apply appropriate dressing e.g mepitel
Pain control
- lignocaine gel (not anusol) topically
- oral analgesia
- consider topical morphine
Diarrhoea/proctitis
- loperamide, codeine phosphate
Admit to ward for symptom control if problems with pain control or hygiene, as gaps in
treatment significantly increase risk of recurrence.
Reinforce motivation as regime is difficult to tolerate both physically and psychologically. Refer
to counsellor if necessary.
8.0 Gaps in Radiotherapy Treatment
Gaps should therefore be avoided when possible.
Consider weekend treatment if bank holidays or unscheduled breaks in treatment occur as per the
departmental policy
9.0 Follow-up
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Follow up 4-6 weeks after treatment completion
2-3 monthly follow up in the first year with Digital Rectal Examination
MRI at 6 monthly intervals for 3 years in high-risk disease. Low-risk disease may require only
one baseline post-treatment MRI.
If evidence of persistent disease then requires EUA and biopsy +/- salvage surgery
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10.0 Side Effects of Radiotherapy Treatment
Acute radiation reaction (settles 4-6 weeks after completing treatment)
Common effects  Diarrhoea
 Proctitis
 Lethargy
 Desquamation
 Urinary frequency
Late radiation reaction (side effects occurring after 6 months)
Possible effects
 Anal dysfunction
 Persistent proctitis
 Change in bowel habit
 Telangiectasia
 Vaginal fibrosis
 Infertility
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